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Durvalumab + Oleclumab

Phase 2

Stage III Non-small Cell Lung Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Oct 8, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment189
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03822351Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLCPHASE2 COMPLETED 189 — — Dec 19, 2018Jul 18, 2023Oct 8, 202473 United States, Canada +7
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Study Endpoints
Primary Endpoints
Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint

ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.

Secondary Endpoints
Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
From time of signature of informed consent up to 15 months post the first dose of study treatment
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
From baseline up to 15 months post the first dose of study treatment
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
From baseline up to 15 months post the first dose of study treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Control Arm (Durvalumab monotherapy)EXPERIMENTALdurvalumab IV
Arm A (durvalumab + oleclumab):EXPERIMENTALdurvalumab IV and oleclumab IV
Arm B (durvalumab + monalizumab)EXPERIMENTALdurvalumab IV and monalizumab IV
Interventions
NameTypeDescription
Durvalumab + OleclumabDRUGDurvalumab + Oleclumab
DurvalumabDRUGDurvalumab
Durvalumab + MonalizumabDRUGDurvalumab + Monalizumab
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites73

Main Inclusion Criteria: 1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation 2. Age 18 years or older 3. Body weight ≥ 35 kg 4. Subjects must have histologically or cytologic...

Countries:United StatesCanadaFranceHong KongItalyPolandPortugalSpainTaiwan
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